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Enrolling by Invitation

NCT Number: NCT05530356

Renal Hemodynamics, Energetics and Insulin Resistance: A Follow-up Study

The current protocol plans to enroll participants with youth-onset Type 2 Diabetes (T2D) as well as obese and lean controls from the Renal-HEIR - Renal Hemodynamics, Energetics and Insulin Resistance in Youth Onset Type 2 Diabetes Study (n=100) [COMIRB #16-1752] in a prospective investigation that seeks to 1) define the changes in kidney function by gold standard techniques and energetics by functional Magnetic Resonance Imaging (MRI) in adolescents with and without T2D as they transition to young adulthood; 2) quantify kidney oxidative metabolism by 11C-acetate Positron Emission Tomography (PET) in a subset of participants who are ≥18 years of age with youth-onset T2D and/or obesity; 3) determine peripheral arterial stiffness by SphygmoCor. Mechanistic insight will be provided by transcriptomic analyses of repeat biopsies 3-years after their initial biopsy for eligible participants with youth-onset T2D, as well as molecular analysis of tissue obtained from J-wire endovascular biopsies. This study will also leverage this well-characterized cohort of youths to define youth-onset T2D-related changes in brain morphology and function by structural MRI and resting-state functional MRI and through the assessment of cognitive function (fluid and crystallized intelligence) using the NIH Toolbox Cognitive Battery (NIHTB-CB), as an exploratory objective. All enrollees in Renal-HEIR have consented to be contacted for future research opportunities.

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Key information

Conditions

Type 2 Diabetes Adolescent Obesity Body Weight Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes Type 2 Diabetic Kidney Disease Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nephropathy Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

12 year–26 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Obese youth with and without Type 2 Diabetes + lean controls who were previously enrolled in the Renal HEIR Study
  • Participants who will undergo a PET Scan: ≥ 18 years

Exclusion criteria

  • Anemia
  • Seafood, iodine, or penicillin allergy
  • Pregnancy
  • MRI Scanning contraindications (claustrophobia, implantable devices, >550 lbs)
  • History of bleeding or clotting disorders, thrombocytopenia, warfarin and/or heparin use
  • Taking sulfonamides, procaine, thiazolsulfone or probenecid

Treatment and study plan

Aminohippurate Sodium Inj 20%

Drug

Diagnostic aid/agent used to measure effective renal plasma flow (ERPF)

Other names: Sodium 4-amino hippurate (PAH) inj 20% 2g/10mL, Para-aminohippurate, Aminohippuric acid

Iohexol Inj 300 mg/mL

Drug

Diagnostic aid/agent used to measure glomerular filtration rate (GFR)

Other names: omnipaque 300

Dextran 40

Drug

Diagnostic aid/agent used to measure glomerular size selectivity

Other names: Dextran, LMD

Renal Biopsy

Procedure

Minimally invasive outpatient procedure in interventional radiology to obtain renal tissue cores.

Other names: Kidney Biopsy

Positron Emission Tomography

Radiation

Imaging study performed to study renal oxidative metabolism

Other names: PET Scan

Primary outcomes

  1. Effective Renal Plasma Flow (ERPF)

    Time frame: 4 Hours

    Measured by PAH clearance

  2. Glomerular Filtration Rate

    Time frame: 4 Hours

    Measured by Iohexol Clearance

  3. Glomerular Size Selectivity

    Time frame: 4 hours

    Measured by Dextran sieving

  4. Renal Oxygen Availability

    Time frame: 1 hour

    Measured by functional kidney MRI

  5. Renal Perfusion

    Time frame: 1 hour

    Measured by functional kidney MRI + PET Scan

  6. 11-C Acetate Tracer Uptake

    Time frame: 1 Hour

    Measured by PET Scan

  7. Renal Oxidative Metabolism

    Time frame: 1 Hour

    Measured by PET Scan

  8. Blood Volume Fraction

    Time frame: 1 Hour

    Measured by PET Scan

  9. Glomerular Basement Membrane Width

    Time frame: 1 Hour

    Measured by Renal Biopsy

  10. Mesangial Expansion

    Time frame: 1 Hour

    Measured by Renal Biopsy

  11. Interstitial Fibrosis

    Time frame: 1 Hour

    Measured by Renal Biopsy

  12. Renal Arteriosclerosis

    Time frame: 1 Hour

    Measured by Renal Biopsy

  13. Spatial Transcriptomics

    Time frame: 1 Hour

    Measured by Renal Biopsy

  14. Spatial Metabolomics

    Time frame: 1 Hour

    Measured by Renal Biopsy

Secondary outcomes

  1. Pulse Wave Velocity between Carotid and Femoral Artery

    Time frame: 10 minutes

    Measured by PWV

  2. Whole brain gray matter volume

    Time frame: 1 Hour

    Measured by brain MRI

  3. Whole brain cortical thickness

    Time frame: 1 Hour

    Measured by brain MRI

  4. Whole brain resting-state network connectivity

    Time frame: 1 Hour

    Measured by brain MRI

  5. Age-corrected composite fluid cognition score

    Time frame: 1 Hour

    Measured by brain MRI

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

Renal Hemodynamics, Energetics and Insulin Resistance in Youth Onset Type 2 Diabetes: A Follow-up Study

Acronym: HEIRitage

Important dates

Study start
2022
Primary completion
2027
Study completion
2029
First posted
Sep 7, 2022
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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